Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)

The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.

Inclusion Criteria:

• Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
• Patients assessed as positive in the SLR test.
• Patients with sciatica in either lower leg.
• Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.

Exclusion Criteria:

• Patients who have 2 or more lumbar disc herniations as assessed by MRI.
• Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
• Patients who have received nerve block within 3 weeks before screening.
• Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.